Retiro De Equipo (Recall) de Device Recall VITROS 4600 Chemistry System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Ortho-Clinical Diagnostics.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Causa
    Increased u90-382 or 6lu condition codes generated by vitros 250, 350, 5,1 fs, 4600 and 5600 chemistry systems when using calibrator kit 9, lot 954. a trend of complaints regarding customers actions following u90-382 or 6lu condition codes was noted (see res 72289 - vitros calibrator kit 9, lot 954 recall).
  • Acción
    Ortho Clinical Diagnostics sent an URGENT PRODUCT CORRECTION NOTIFICATION Letter (Ref. CL2015-201, dated December 21, 2015) via FedEx overnight courier and/or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address). The notification letter was sent to all customers who received the affected product. Foreign affiliates were informed by e-mail on 12/20/2015 of the issue and instructed to notify their consignees of the issue and required actions. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Technical Services at 1-800-421-3311.


  • Modelo / Serial
    Software Version 3.2 and below; Serial Numbers J46000001 - 46000678
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - US Nationwide including Puerto Rico, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela
  • Descripción del producto
    VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343; IVD. || Product Usage: || For in vitro diagnostic use. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)
  • Manufacturer


  • Dirección del fabricante
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • Empresa matriz del fabricante (2017)
  • Source